MTD defined as the dose level below the lowest dose that induces dose-limiting toxicity in at least one-third of patients assessed by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0

Best response defined as best objective status recorded from the start of the treatment until disease progression/recurrence assessed by modified RECIST criteria

Phase II: Clinical Benefit of oleclumab in combination with chemotherapy and durvalumab by the comparing the CB rate at 24 weeks from the 1st dose of study drug administration between patients treated with or without the anti-CD73 antibody oleclumab

Safety of NKTR-214 in combination with nivolumab as evaluated by incidence of drug-related Adverse Events (AEs), Serious Adverse Events (SAEs), and adverse events leading to discontinuation, deaths, and clinical laboratory test abnormalities

Safety of NKTR-214 in combination with nivolumab and ipilmumab as evaluated by incidence of drug-related AEs, SAEs, and adverse events leading to discontinuation, deaths, and clinical laboratory test abnormalities

Tolerability of NKTR-214 in combination with nivolumab as evaluated by incidence of Dose Limiting Toxicities (DLTs), drug-related AEs, SAEs, adverse events leading to discontinuation, deaths and clinical laboratory test abnormalities

To establish a safe dose of PLD when delivered in combination with pembrolizumab

To evaluate the Tumor Response Rate according to Response Evaluation Criteria in Solid Tumors (RECIST) after 9 weeks (3 cycles) of treatment in patients with measurable disease.

To evaluate the safety and DLT of the PLD and pembrolizumab combination, as indicated by the number of study participants with treatment-related Adverse Events, and the class of Adverse Events as assessed by CTCAE v4.0.

To characterize the PK of PLD when delivered in combination with pembrolizumab, by measuring and comparing the Area under the curve (AUC) for doxorubicin (liposomal) obtained during Cycles 1 and 3.

Maximum tolerated dose (MTD), or the maximum tested dose at which multiple dose-limiting toxicities (DLTs) are not observed, of RGX-104 as a single agent, and separately, in combination with nivolumab.

Overall response rate associated with RGX-104 treatment as a single agent, and separately, in combination with nivolumab.

Progression-free survival associated with RGX-104 treatment as a single agent, and separately, in combination with nivolumab.

(and 3 more...)

150

All

18 Years and older (Adult, Older Adult)

NCT02922764

RGX-104-001

November 2016

June 2019

October 2019

October 4, 2016

March 2, 2018

Cedars-Sinai Medical CenterLos Angeles, California, United States

University of California, Los AngelesLos Angeles, California, United States

Incidence of dose limiting toxicities (DLTs) of TPST-1120 as a single agent and in combination with nivolumab, in combination with docetaxel and in combination with cetuximab.

Incidence of treatment-emergent adverse events as assessed by NCI-CTCAE v5.0 of TPST-1120 as a single agent and in combination with nivolumab, in combination with docetaxel and in combination with cetuximab.

Progression Free Survival (PFS) as measured by the duration from the date of first dose until the earliest date of disease progression or death as measured by immune-related Response Evaluation Criteria In Solid Tumors (irRECIST) v1.1

Duration of response (DOR) as measured from the time of the earliest response complete response (CR) or partial response (PR) until disease progression per irRECIST v1.1

237

All

18 Years and older (Adult, Older Adult)

NCT02646748

39110-107

January 2016

June 2019

August 2019

January 6, 2016

December 3, 2018

University of California San Francisco Helen Diller Family Comprehensive Cancer CenterSan Francisco, California, United States